About the Job:

This role is responsible for end-to-end ownership of Foundation Medicine’s global CAPA program for regulated medical devices and IVDs. This role provides strategic program leadership, governance, and operational oversight to ensure investigations and corrective actions are timely, risk-based, effective, and inspection ready.

As a core member of the Post Market Device Quality leadership team, this role partners closely with Regulatory Affairs, Quality Systems, Complaints, Risk Management, Lab Operations, and business stakeholders to identify systemic quality issues, drive meaningful remediation, and prevent recurrence. This role plays a critical part in enabling organizational learning, continuous improvement, and sustained patient safety through a mature and scalable CAPA program. 

This role leads and develops a team of quality professionals and strengthens investigation of quality and decision-making capability across the organization, applying sound judgment in complex, highly regulated environments. 

Key Responsibilities:

• Global CAPA Program Leadership 
  • Own the global CAPA program strategy and execution across FMI, ensuring a risk-based, effective, and inspection-ready approach to issue identification, remediation, and prevention. 
  • Establish clear expectations for investigation of quality, root cause analysis, corrective and preventive actions, and effectiveness of verification. 
  • Partner with senior Quality leadership to align CAPA governance with broader Post Market Device Quality systems. 
• Cross Functional Partnership & Risk Management 
  • Partner with cross functional stakeholders (Quality, Regulatory Affairs, Operations, Laboratory, IT, and Clinical/Lab interfaces) to identify systemic quality risks and drive meaningful, sustainable improvements. 
  • Serve as a subject matter expert on post market device quality investigations, risk assessment, and CAPA decision making across IVDs and clinical trial interfaces. 
  • Ensure CAPA outputs appropriately inform Complaints, Risk Management, Issue Impact Assessments, and Management Review. 
• Data, Metrics & Technology Enablement 
  • Develop, monitor, and communicate CAPA related KPIs, trends, and systemic risks to Quality leadership and senior governance forums. 
  • Lead enhancements to CAPA workflows, data integrity, reporting, and system performance. 
  • Act as the CAPA business owner and quality representative for technology initiatives, ensuring solutions are compliant, scalable, and fit for purpose. 
• Inspection Readiness & Regulatory Support 
  • Serve as a CAPA subject matter expert during regulatory inspections, audits, and internal governance reviews. 
  • Ensure inspection ready documentation, clear investigation narratives, and defensible corrective action strategies. 
• People Leadership & Capability Building 
  • Lead, coach, and develop a team of quality professionals, strengthening investigation rigor, critical thinking, and quality judgment. 
  • Partner with Quality and functional leaders to project CAPA demand and resource needs to maintain program sustainability. 
  • Drive continuous improvement through trend analysis, effectiveness reviews, and lessons learned to reduce patient and business risk. 

Qualifications:

Basic Qualifications:

• Bachelor's degree in science, engineering or related field
• 6+ years of experience in quality, IVDR, medical device, or other regulated biotechnology environments
• 2+ years of management experience

Preferred Qualifications:

• Demonstrated experience harmonizing CAPA practices across multiple sites or regions.    
• Experience supporting or leading eQMS implementation or optimization, including collaboration with IT and business stakeholders.    
• Experience serving as a CAPA or QMS subject matter expert during regulatory inspections (e.g., FDA, ISO, MDSAP).    
• Familiarity with clinical laboratory quality systems (CLIA) and interfaces between laboratory, device, and clinical trial quality.    
• Experience applying lean principles or continuous improvement methodologies within quality systems.    
• Knowledge of or experience with next-generation sequencing (NGS), molecular diagnostics, or complex laboratory technologies.   
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving.   
• Strong conceptual, analytical, and problem-solving abilities.  
• Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines  
• Ability to travel based on business needs, typically 10-20%, but flexing higher when needed.   
• Understanding of HIPPA and importance of patient data privacy   
• Commitment to reflect FMI’s values: Integrity, Courage, and Passion 

The expected salary range for this position based on the primary location of Remote is $160,000 – $199,500 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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